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Adjuvant treatment with Pramipexole for anhedonia symptoms in depression - PRIME-PRAXOL
EU CTIS ID: 2024-512495-35-00
What this study is testing
Will treatment with pramipexole at the highest possible dosage (without intolerable adverse reactions, max 3.15 mg base) reduce anhedonia symptoms over a nine-week period compared to placebo treatment?
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years ≤75 years.
- Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia.
- Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).
- Ongoing treatment with at least one antidepressant or mood stabilizing medication ≥ 4 weeks.
- Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression).
- The research subject has given informed consent to participate in the study.
You likely can't join if
- Pregnancy, breastfeeding or planned pregnancy (if female).
- Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
- Ongoing or planned ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
- Other medical conditions or other concomitant drug treatment which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, bariatric surgery with a known impact on absorption of extended-release tablets.
- Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
- Participation in other treatment studies.
See the full eligibility criteria
- Age ≥18 years ≤75 years.
- Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia.
- Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).
- Ongoing treatment with at least one antidepressant or mood stabilizing medication ≥ 4 weeks.
- Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression).
- The research subject has given informed consent to participate in the study.
- Pregnancy, breastfeeding or planned pregnancy (if female).
- Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
- Ongoing or planned ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
- Other medical conditions or other concomitant drug treatment which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, bariatric surgery with a known impact on absorption of extended-release tablets.
- Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
- Participation in other treatment studies.
- Other reason, as assessed by the investigator, that prevents the research subject's participation, such as the risk that the research subject is unable to complete the trial (non-compliance).
- High suicide risk according to the overall clinical assessment of the research physician.
- Ongoing substance abuse (within 6 months).
- Diagnosis of current psychosis.
- Known diagnosis of Emotionally Unstable Personality Disorder.
- Treatment under LPT.
- History of or a strong clinical suspicion of impulse control disorder (including current bingeeating disorder) or a current ADHD diagnosis with hyperactivity.
- Diagnosis of intellectual disability, dementia, or other circumstance that makes it difficult to understand the meaning of participating in the trial and give informed consent.
- Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.